NCT06381115NARecruiting
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
Mayo Clinic
Start Date
6/1/2025
Completion Date
7/1/2026
Summary
The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.
* In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
* Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who:
* Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study;
* Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance;
* Are prescribed continuous or auto-titrated CPAP;
* Agree to using a smartphone application and wearable wrist sensor; and
* Speak and read English.
Exclusion Criteria:
* Unwilling to complete study measures and engage with SleepWell24;
* Refuse to not use the Fitbit application during the study trial;
* Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions);
* Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.);
* Decide to use a different PAP device than ResMed Airsense 10;
* Prescribed high-dose benzodiazepines (equivalent to \> 1 mg lorazapam/night);
* Daily opioid medication use at night;'
* Unwilling to discontinue use of any current wearable sensor for the duration of the trial;
* Previous documented history of treatment/referral for claustrophobia;
* Previous CPAP use;
* Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and
* Currently pregnant, trying to conceive, or breastfeeding.
Interventions
BEHAVIORAL
SleepWell24 Application
Conditions
Obstructive Sleep Apnea
Locations
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States